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FDA 510(k)

VIVACE Electrosurgical System

K-Number: K150409 · 2016-01-15

ApplicantSung Hwan E&B Co.,Ltd
Decision Date2016-01-15
Product CodeOUH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VIVACE Electrosurgical System is the device name listed in this FDA 510(k) record. The listed applicant is Sung Hwan E&B Co.,Ltd. It received FDA 510(k) clearance on 2016-01-15 under 510(k) number K150409. The device is classified under product code OUH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIVACE Electrosurgical System?

VIVACE Electrosurgical System is a medical device that received FDA 510(k) clearance on 2016-01-15. The listed applicant is Sung Hwan E&B Co.,Ltd. The 510(k) number is K150409.

When did VIVACE Electrosurgical System receive FDA 510(k) clearance?

VIVACE Electrosurgical System received FDA 510(k) clearance on 2016-01-15, under 510(k) number K150409.

Who is the listed applicant for VIVACE Electrosurgical System?

The FDA 510(k) record lists Sung Hwan E&B Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VIVACE Electrosurgical System?

The FDA product code for VIVACE Electrosurgical System is OUH.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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